Duns Number:002207751
Device Description: Bipolar Pencil, 18 Gauge Disposable Straight
Catalog Number
-
Brand Name
Bausch & Lomb
Version/Model Number
E7918
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K864402,K864402
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
7174af6a-81c2-4a01-ac60-2b1c52c41cbe
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 31, 2016
Package DI Number
20757770457278
Quantity per Package
10
Contains DI Package
00757770457274
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 77 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 134 |
| 3 | A medical device with high risk that requires premarket approval | 3348 |
| U | Unclassified | 1 |